Tosoh Bioscience recalls ST-AIA PACK cTnI 2nd Gen cardiac assay kits due to potential false test results from Asfotase Alfa (Strensiq) interference. All lot codes affected.
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Tosoh Bioscience is recalling ST-AIA PACK cTnI 2nd Gen cardiac assay kits because they can give false high or low results when used with Asfotase Alfa (Strensiq). This could lead to incorrect medical decisions if the test is part of a patient's care.
Asfotase Alfa (Strensiq) can interfere with certain cardiac marker tests, causing the results to be too high or too low. This might lead to incorrect medical decisions if the test is part of a patient's care.
Patients using cardiac marker tests with Asfotase Alfa (Strensiq) may be affected. Those with specific medical conditions requiring precise cardiac testing are most at risk.
Check for the ST-AIA PACK cTnI 2nd Gen assay kit with Part Number 025205. All lot codes are affected by this recall.
Verify if your kit has the Part Number 025205 and is labeled as ST-AIA PACK cTnI 2nd Gen.
No, the recall does not require stopping use. The product can still be used but may give inaccurate results when combined with Asfotase Alfa (Strensiq).
The recall does not specify a remedy, so no action is needed beyond checking if you have the affected product.
The product may give false results when used with Asfotase Alfa (Strensiq), so it's not safe for accurate cardiac testing in those cases.
We’ve drafted a message you can send Tosoh Biosc: Inc to request your refund or repair — edit it as you like.
Subject: Recall Z-2073-2018 — Tosoh Biosc: Inc Tosoh Biosc: Inc Hello, I own a Tosoh Biosc: Inc that is covered by recall Z-2073-2018 from Tosoh Biosc: Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
